We aim to explain our rationale for a ground ambulance cold stored low-titer ORhD+ whole blood (LTO+WB) program.
In the greater San Antonio metro area, the South Texas Blood and Tissue Center (STBTC), UT Health San Antonio, University Health System, San Antonio Military Medical Center, US Army Institute for Surgical Research, San Antonio Medical Foundation and Southwest Texas Regional Advisory Council for Trauma (STRAC) collaborated to incorporate LTO+WB administration into all phases of their trauma system.1
The San Antonio Fire Department EMS (SAEMS) began using cold stored LTO+WB in October 2018 to treat hemorrhagic shock.
Every year, prehospital hemorrhagic shock due to injury accounts for approximately 25,000 civilian deaths.2 Hemorrhage related deaths from other causes remains unquantified. One of the primary functions of emergency medical services (EMS) is to decrease morbidity and mortality for these patients by providing remote damage control resuscitation. Remote damage control resuscitation consists of hemorrhage control, hypotensive resuscitation, and when possible the administration of prehospital blood products.2-5
A balanced transfusion is best because no single blood component can fix the severe oxygen debt, endotheliopathy, platelet dysfunction, and coagulopathy of hemorrhagic shock.6,7 However, providing a balanced transfusion in the prehospital setting had been logistically prohibitive. To fill this capability gap, the San Antonio Fire Department EMS (SAEMS) turned to cold stored LTO+WB.
The SAFD is the sole 911 provider for a population of 1.5 million people spread over 460-square-miles. The UTHSCSA, Department of Emergency Health Services, Office of the Medical Director (OMD) provides medical direction for the SAFD. The SAFD EMS operational plan to deliver LTO+WB includes one unit (approximately 520mL) of LTO+WB on EMS physician response vehicles, EMS medical officer (MOF) supervisor vehicles, and medical special operations unit (MSOU) mobile intensive care ambulances. If the EMS physician, MOF or MSOU medic arrives on the scene before ambulance departure, the LTO+WB and infusion equipment will be transferred to the transporting crew for ongoing transfusion during transport. It has been standard practice for the transfusion of the initial field LTO+WB to be completed in the ER if not already done during transport. All involved parties have adopted this behavior to maximize the therapeutic effects for the patient while also being conscientious stewards of the LTO+WB resource.
SAFD EMS transfuses LTOWB to any patient experiencing massive hemorrhage and signs of significant hypoperfusion. In our system, we define significant hypoperfusion as systolic blood pressure (SBP) <70 or SBP < 90 with a pulse 110 or greater and end-tidal carbon dioxide (ETCO2)<25. We based the SBP and pulse criteria on two recent trials of prehospital plasma transfusion which found mortality ranging from 10% to 33% in their control arms8,9 However, previous data suggest clinically significant hypoperfusion may occur before a patient’s SBP reaches 90mm Hg.10-14 We included ETCO2 < 25 mm Hg in our criteria to identify these patients. Due to its relationship with pulmonary blood flow and cardiac output, ETCO2 falls during shock states.15-17 The relationship between abnormally low ETCO2 and trauma patient outcomes is present in numerous prehospital, emergency department and operating room based studies.18-26
SAEMS will also transfuse whole blood to select patients in cardiac arrest as a result of traumatic and non-traumatic hemorrhagic shock. To date, SAEMS has had one EMS witnessed traumatic cardiac arrest, due to blunt trauma, that received prehospital whole blood and survived to hospital discharge. We also had a patient with multiple chronic medical conditions get whole blood after arresting secondary to massive hemoptysis. That patient had ROSC in the field and lived for several hours after his whole blood transfusion.
Trauma and medical patients in hemorrhagic shock or arrest should receive whole blood when available.
The primary technique for deployment of whole blood to patients in hemorrhagic shock shall consist of:
Response by a medical supervisor to the scene to deploy whole blood and assist with transfusion of patient
Response by EMS unit to the scene to transfuse whole blood
Response by EMS physician unit to the scene to transfuse whole blood
Response by SAFD/SAPD helicopter or ground units to assist with MCI deployment and transfusion of whole blood
INDICATIONS for Transfusion of LTOWB:
Hemorrhagic Shock in Traumatic and Medical Patients with any one of the following
Systolic Blood Pressure < 70 mmHg
Systolic Blood Pressure < 90 with HR ≥ 110 beats per min
ETCO2 < 25
Witnessed arrest from hemorrhage or suspected hemorrhage < 5 min prior to provider arrival and continuous CPR throughout downtime
Age ≥ 65 yo and SBP ≤ 100 mmHg with HR ≥ 100 beats per minute
Contraindications for Whole Blood Transfusion:
Religious objection to human blood products.
RELATIVE CONTRAINDICATIONS for Whole Blood Transfusion:
Patients less than six years old will require consultation with EMS Medical Direction to determine eligibility for whole blood transfusion and assist with the precise management of infusion parameters. The SAFD units are supplied with a Burette Set for use on indicated pediatric patients to achieve the aforementioned precision in LTO+WB transfusion. This relative contraindication is based upon safety. A large single bolus of the full volume of the bag (520 cc) may have a negative impact on a child less than six years old.
Patients may refuse whole blood administration due to personal or religious beliefs. Paramedics will inform patient that blood products may save their lives, but ultimately any patient with decision-making capacity may refuse treatment.
Children of caregivers that do not wish to have their children receive blood will require a consult with EMS Medical Direction to determine an appropriate course of action.
The SAFD will follow all federal and local laws and will reference the local county hospital transfusion guidelines in regards to patient refusal of blood products.
Challenges and Processes:
Transition to transfusing whole blood in the prehospital environment to all patients in hemorrhagic shock has many practical, logistical and financial challenges. Practically, the deployment of whole blood in the civilian setting has not been proven to translate from the military battlefield to the urban, suburban or rural peacetime setting. Logistically, the deployment of low titer O+ whole blood requires multiple vested partners and a substantial time commitment. A blood bank partner and hospital partners are critical to program success. Whole blood must be kept at 1-6°C if stored and 1-10° C if in transport. LTO+WB will be switched out for new blood every 21-35 days depending upon the preservative used for prolonged storage. These limitations require a detailed plan, comprehensive validation program, dedicated staff to accomplish the daily routine of keeping blood available for the EMS system and a strict quality assurance program to assess compliance with protocols and measure complications and outcomes. The programs implemented to affect compliance and outcomes include; performance improvement and quality assurance on every patient, ongoing regional whole blood meetings and twice daily updates on whole blood par levels for all vested partners in the region. Using such a quality assurance mechanism, several system improvements were made since the inception of this program, while no major complications have been identified. Financial and infrastructure constraints may make it impossible to fully deploy cold-stored whole blood in many EMS systems.
Hemorrhagic shock patients will preferentially receive low titer O+ whole blood. These patients will meet criteria for transfusion of whole blood as determined by the OMD and SAFD.
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CJ Winckler, MD, LP – Deputy Medical Director SAFD EMS
Julian Mapp, MD, MPH, MBA – Associate Medical Director SAFD EMS
David Wampler, PhD., LP, FAEMS – Director of Clinical Research OMD
Randi Schaefer, RN, – Director of Clinical Research STRAC
David Miramontes, MD, FACEP, FAEMS – Medical Director SAFD EMS
Chief Michael Stringfellow, LP – Chief of SAFD EMS
Lieutenant William Bullock, EMT-P – SAFD EMS
Donald Jenkins, MD, FACS
C.J. Winckler serves as the Deputy Medical Director for the San Antonio Fire Department and is an Assistant Clinical Professor at the University of Texas San Antonio Health Science Center in both the Department of Emergency Health Sciences and the Department of Emergency Medicine.
David Wampler, PhD, LP, is an Assistant Professor of Emergency Health Sciences, and director of prehospital medicine research at The University of Texas Health Science Center at San Antonio.